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Completed

NCT Number: NCT00569751

TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

The TAXUS ARRIVE 2 study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low frequency TAXUS related clinical events.

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Key information

Conditions

Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases de Novo Coronary Lesions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Scottsdale Healthcare, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Appropriate Patient Criteria:

  • Patient is eligible to receive a Boston Scientific TAXUS Stent

Inappropriate Patient Criteria:

  • Known sensitivity to paclitaxel.
  • Known allergy to stainless steel.
  • Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated.
  • Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.
  • Patients with unresolved vessel thrombus at the lesion site.
  • Patients with coronary artery reference vessel diameters less than 2.5 mm or greater than 3.75 mm.
  • Patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation.
  • Patients with diffuse disease or poor overflow distal to the identified lesions.
  • Patients with tortuous vessels in the region of the obstruction or proximal to the lesion.
  • Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.

Treatment and study plan

TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System

Device

Drug Eluting Stent used to treat de novo coronary artery lesions.

Primary outcomes

  1. Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC).

    Time frame: 1-year post-implant procedure

Secondary outcomes

  1. Rate of TAXUS stent related cardiac events as classified by the CEC.

    Time frame: within 30 days, 6 months and 2 years

  2. Rate of target vessel related cardiac events as classified by the CEC.

    Time frame: 30 days, at 6 months, at 1 and 2 years post-implant procedure

  3. Rate of other TAXUS related events

    Time frame: 30 days, 6 months, 1 and 2 years post-implant procedure

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: ARRIVE 2

Important dates

Study start
2004
Primary completion
2006
Study completion
2008
First posted
Dec 7, 2007
Registry last updated
Sep 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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